Enzo Biochem’s subsidiary Enzo Clinical Labs has reached an agreement with IncellDx to acquire marketing rights of a cervical cancer diagnostic test.
IncellDx is a molecular diagnostics company dedicated to the detection and monitoring of life threatening diseases such as cervical cancer, HIV/AIDS, hepatitis and organ transplant rejection.
IncellDx’s proprietary laboratory test is based upon HPV OncoTect, an advanced molecular diagnostic technology for quantifying specific biomarkers that have been associated with an increased risk of progression to cervical cancer.
HPV OncoTect is a novel method for screening for the likelihood of progression to cervical carcinoma by measuring potential oncogenic activity of the human papillomavirus (HPV) in infected cervical cells.
The assay functions by detecting and quantifying the expression of viral oncogenes responsible for triggering progression to cervical cancer, thus improving the specificity that existing tests lack.
HPV OncoTect will be validated during in-house studies prior to seeking New York State approval under a ‘LDT’ regulatory pathway.
Upon receiving the appropriate approvals, Enzo will become the first New York licensed reference laboratory to offer the test.